ISO 13485 Complaints (what is a complaint)

J

joylc

#1
My company is working toward getting ISO 13485 certification (we are currently ISO 9001 certified). I'm reviewing and updating our current procedures and found a practice in our complaint handling system that I don't think is acceptable. I'm hoping for some input to either confirm or overrule my opinion.

Here is an example of what is happening:
A customer complains that the product has a blue appearance and provides a photo showing two products, the complaint product that has a blue tint and a previously received product that looks off white. The complaint is logged into the system as a complaint. The quality engineer reviews the complaint and the product and determines that the blue tint is natural process variation. The QE then reclassifies the record in the system so it is no longer a complaint but is instead called something else.

To me, even if the product meets specification, it is still a complaint based on the ISO definition which only requires an allegation of deficiency and we shouldn't be reclassifying complaints into a new category. Once the complaint is reclassified, it doesn't appear on any complaint reports or in the complaint metrics which I was told was the reason for the reclassification. To me, the better approach would be to break the metrics down into confirmed (allegation was substantiated) and not confirmed (allegation was not substantiated).

Thoughts?
 
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NikkiQSM

Quite Involved in Discussions
#3
We keep the classification of the complaint, a complaint, regardless if we were at fault or not.

During our management reviews, we discuss and review all complaints, and we would categorize the complaints where we were at fault, as "True Complaints".
 
R

RoneyJames

#4
I think, it is not a complaint made manually, it is something occurred due to the fault of the machine.
 

somashekar

Staff member
Admin
#5
My company is working toward getting ISO 13485 certification (we are currently ISO 9001 certified). I'm reviewing and updating our current procedures and found a practice in our complaint handling system that I don't think is acceptable. I'm hoping for some input to either confirm or overrule my opinion.

Here is an example of what is happening:
A customer complains that the product has a blue appearance and provides a photo showing two products, the complaint product that has a blue tint and a previously received product that looks off white. The complaint is logged into the system as a complaint. The quality engineer reviews the complaint and the product and determines that the blue tint is natural process variation. The QE then reclassifies the record in the system so it is no longer a complaint but is instead called something else.

To me, even if the product meets specification, it is still a complaint based on the ISO definition which only requires an allegation of deficiency and we shouldn't be reclassifying complaints into a new category. Once the complaint is reclassified, it doesn't appear on any complaint reports or in the complaint metrics which I was told was the reason for the reclassification. To me, the better approach would be to break the metrics down into confirmed (allegation was substantiated) and not confirmed (allegation was not substantiated).

Thoughts?
If the blue tint is a natural process variation, please include this into your "Information provided to user" (either the IFU or the manual) that you are providing.
 
E

EthanLoh

#6
In the ISO 13485: 2016, it should be classified as "Feedback" clause 8.2.1.

The flow should be as follow.

Feedback from customer --> Meet complaint definition? --> No --> Log as customer feedback. Review and monitor, if needed.

Feedback from customer --> Meet complaint definition? --> Yes --> Manage as a customer complaint --> Meet MDR requirements? --> Yes --> Report to US FDA --> Meet Recall requirements? --> Perform recall and report to US FDA.
 
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